FDA.reportPublic FDA data

Sterile Water

Product NDC
0517-3005
Requested package NDC
0517-3005-25
11-digit product format
005173005
Labeler code
0517
Product ID
0517-3005_35706fc3-a09c-413b-b077-4554c5914063
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Water
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
American Regent, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
WATER
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0517-30050517-3005-25DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-3005-01Sterile Water5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION58
0517-3005-25Sterile Water25 in 1 TRAYINJECTION, SOLUTION258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-3005-01ML - Milliliter0517-300515098655-1729-443f-a0c8-04ef0a05124712021-04-08
0517-3005-25ML - Milliliter0517-3005c6878d11-5d41-4c8b-b91b-8e7437809e3912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WATERACTIVE INGREDIENT059QF0KO0RSTERILE WATER (WATER) INJECTION, SOLUTION [AMERICAN REGENT, INC.]2
WATERACTIVE MOIETY059QF0KO0RSTERILE WATER (WATER) INJECTION, SOLUTION [AMERICAN REGENT, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-3005STERILE WATER (WATER) INJECTION, SOLUTION [AMERICAN REGENT, INC.]8Legacy NDC, 2 package rows20220422_78b35864-4bbc-4759-a5c1-7e4f25e22932.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
ndc (package): 0517-3005-25
ndc (product): 0517-3005
ndc11 (package): 00517300525

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0517-3005-250051730052525 VIAL, SINGLE-DOSE in 1 TRAY (0517-3005-25) > 5 mL in 1 VIAL, SINGLE-DOSE (0517-3005-01) 1990-09-300000-00-00NoNoCurrent